The Division of Pulmonary, Critical Care and Sleep Medicine has an active translational research program with several NIH grants, as well as corporate and device trials. We provide extensive laboratory facilities with access to cutting-edge techniques. In addition, our animal facilities support ongoing studies involving animal models of human disease (asthma, PAP, sarcoidosis). Targeted research areas include:

At East Carolina University, there is a research effort to understand the biological circumstances that lead to lung disease. As a result, there are several studies being performed that involve different groups of investigators. This is due to the fact that lung diseases are associated with many biological factors which require a "team" approach for investigation. Since several studies involve the use of blood and lung cells obtained during bronchoscopy and residual tissue from lung surgery, we are establishing a "tissue bank" of these specimens. Subjects for these studies will be: 1) patients who come to our Pulmonary Outpatient Clinic for diagnosis and treatment of lung disease 2)patients who undergo surgery for lung disease, and 3) healthy volunteers (controls) who are recruited for this study through advertisement. The subjects may be cigarette smokers. Normal volunteers should be free of acute or chronic respiratory symptoms.

The long-term objective of this study is to delineate the relationships among immune cells, cytokines and anti-GM-CSF autoantibody in PAP pathophysiology. This study will use banked blood samples and banked tissue from bronchoscopy and, therefore, allow the study of lung fluids and cells, as well as systemic cells and mediators from blood. This protocol will enroll 10 patients with PAP being treated with Rituximab under the protocol "Prospective Open-Label Trial for Primary Pulmonary Alveolar Proteinosis," 20 untreated healthy controls for a single bronchoscopy, and 70 untreated healthy controls for a single venous blood draw. The 10 PAP patients will be 18 years of age or older from throughout the United States who have been diagnosed with primary PAP (PAP that develops from unknown reasons).

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-group, Placebo-controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis

This study tests the safety and effectiveness of ustekinumab or golimumab compared to placebo (placebo looks like the drugs being studied, but has no active ingredients). The purpose of this research study is to determine if ustekinumab or golimumab is safe and to determine its effects (good and bad) on patients with sarcoidosis. The study will be conducted at approximately 40 sites globally. Patients can remain on usual, accepted treatment for sarcoid while enrolled in the study. Patients receiving corticosteroids at the beginning of the study will be required to begin tapering at Week 16 of the study. Participating in other experimental studies or taking other experimental medications while participating in this study will not be allowed.

In this sub-study, both the cellular and acellular components present in BAL fluid (BALF) taken from subjects with pulmonary sarcoidosis will be analyzed using a variety of methods including gene microarray technology and proteomic analyses to search for biomarker patterns or "signatures." Previously, gene expression analysis was performed on tissues obtained from patients with sarcoidosis at the time of diagnosis and compared with normal lung tissue (Crouser et al, 2009). In this study, markers that were potential mediators of lung damage, remodeling, and disease activity were identified. By examining the patterns of biomarkers from BAL samples, it may be possible to correlate these patterns with clinical disease and the response to treatment with golimumab and ustekinumab. Thus, BAL has the potential to be a less invasive means than the current gold standard of lung biopsy in the clinical management of sarcoidosis. In addition, the potential of correlating biomarkers in BAL samples with those in serum could lead to minimally invasive and more facile method of diagnosing and managing patients with sarcoidosis. A separate study in normal healthy subjects will also be conducted in which BAL and serum samples will be obtained for comparison with those in this study.

Upon notification and receipt of blinded bronchoalveolar lavage (BAL) cytospin slides from study site, ECU will verify slides received, verify data sheet received, and check in slides for storage. The initial slides undergo a quick overview read within 2 business days in order to provide a quality report and general feedback to the study site in a timely manner. The brief overview read will consist of a 100-cell count looking at cell distributions between squamous cells, bronchial epithelial cells and white blood cells. ECU will report to the study site as to whether the BAL slide is of adequate quality based on several criterions.

Healthy Volunteers Needed for Clinical Study

If you are over 18 years of age with:

No history of lung disease

No history of flu, chest cold, or urinary tract infection for the past six (6) weeks

No current respiratory symptoms

The study will take about four (4) hours and will involve a bronchoscopy study of the lung and/or blood draw.